Head TraumaNCT05195606
The Effect of Auditory and Tactile Stimuli in Traumatic Coma
A study testing Auditory stimulus and Tactile stimulus in people with Head Trauma and Traumatic Coma, run by Akdeniz University.
Trial summary
This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Trauma, Traumatic Coma, Nursing Caries
- What is being tested?
- Auditory stimulus and Tactile stimulus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
- 18 years and older
- Relatives of those who agreed to participate in the study
- GCS score between 3-8 (GCS: 3-8 indicates coma)
- Without hearing impairment
- Having no authority for auditory stimulus
- No problem for foot massage (Lower extremity fracture, infection)
Who cannot join
- Who are under the age of 18
- Those whose relatives do not agree to participate in the research
- GKS score above 8
About this study
Official title: The Effect of Auditory and Tactile Stimulus on Consciousness, Oxygen Saturation, and Mean Arterial Pressure in Traumatic Coma Patients: A Randomized Controlled Single-Blind Study
This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.
Read the detailed description
Background: One of the most important problems experienced by patients treated in the intensive care unit due to traumatic coma is sensory deprivation.
Aim: In this study, it was aimed to examine the effects of auditory and tactile stimulus to be used in the prevention of sensory deprivation on consciousness, oxygen saturation and mean arterial pressure.
Study Design: The study was planned as a randomized controlled single-blind experiment with three groups. In the study, the patients in the Control group will be given a routine application, the patients in the Intervention A group will be given auditory stimuli, and the patients in the Intervention B group will be treated with tactile stimulus. Interventions will be administered once a day for seven days, for a total of seven times. The "block randomization method" was chosen as the randomization method. In this study, hospitals were taken as a block. An equal number of patients will be recruited from two hospitals and 15 patients will be distributed to three groups from each hospital using the "simple randomization method". 30 patients in each group and 90 patients in total will be included in the study.
Methods: The researcher applied to the patients hospitalized in the intensive care unit for 24-72 hours for seven days, once a day (seven times in total) between 10:00 and 15:00 (Intervention A: 10 minutes of audio recording will be played with headphones. Intervention B: 10 minutes) (5 minutes for one foot) foot massage will be applied. Glaskow Coma Score, oxygen saturation and Mean Arterial Pressure will be measured before and after each intervention (twice daily).
- Conditions
- Head Trauma, Traumatic Coma, Nursing Caries
- Being tested
- Auditory stimulus, Tactile stimulus
- Keywords
- Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma
- Medical subject headings
- Craniocerebral Trauma, Coma, Post-Head Injury, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory stimulusOther
Auditory stimulus will be applied to the patients in intervention group A. For the auditory stimulus, the sound recording of the relatives of the patients will be taken and the patients will be listened to with headphones.
Tactile stimulusOther
Tactile stimulus will be applied to the patients in the intervention group B. The tactile stimulus will be performed by the researcher with a foot massage to be applied to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There is no standard sensory stimulation program for comatose patients with head trauma in the hospitals where the research will be conducted. Therefore, the control group will receive routine practice. |
| Auditory stimulus (Intervention A) | Experimental | Auditory stimulus for patients in this group Receives: Other: Auditory stimulus |
| Tactile stimulus (Intervention B) | Experimental | Tactile stimulus for patients in this group Receives: Other: Tactile stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Scale (GCS)
GCS is a diagnostic tool that provides objective evaluation of the patient's eye-opening, verbal and motor response to stimuli. In the scale, the eye opening score is between 1-4, the verbal response is between 1-5, and the motor response is between 1-6, and the total score is between 3-15. The GCS score of the patient who did not respond to painful stimuli, could not open his eyes spontaneously, and had complete loss of muscular tone was three; The GCS score of the patient who is oriented, spontaneously opens his eyes and fulfills the orders is 15. It should be understood that the patient with a GCS score of less than eight is in a coma.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arş. Gör. Arzu TAT ÇATAL, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195606
- Sponsor's protocol ID
- KAEK-724
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auditory and Tactile Stimulus on Consciousness, Oxygen Saturation, and Mean Arterial Pressure in Traumatic Coma Patients: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT05195606
- Acronym / sponsor ID
- KAEK-724
- Conditions
- Head Trauma, Traumatic Coma, Nursing Caries
- Keywords
- Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.
Detailed description
Background: One of the most important problems experienced by patients treated in the intensive care unit due to traumatic coma is sensory deprivation.
Aim: In this study, it was aimed to examine the effects of auditory and tactile stimulus to be used in the prevention of sensory deprivation on consciousness, oxygen saturation and mean arterial pressure.
Study Design: The study was planned as a randomized controlled single-blind experiment with three groups. In the study, the patients in the Control group will be given a routine application, the patients in the Intervention A group will be given auditory stimuli, and the patients in the Intervention B group will be treated with tactile stimulus. Interventions will be administered once a day for seven days, for a total of seven times. The "block randomization method" was chosen as the randomization method. In this study, hospitals were taken as a block. An equal number of patients will be recruited from two hospitals and 15 patients will be distributed to three groups from each hospital using the "simple randomization method". 30 patients in each group and 90 patients in total will be included in the study.
Methods: The researcher applied to the patients hospitalized in the intensive care unit for 24-72 hours for seven days, once a day (seven times in total) between 10:00 and 15:00 (Intervention A: 10 minutes of audio recording will be played with headphones. Intervention B: 10 minutes) (5 minutes for one foot) foot massage will be applied. Glaskow Coma Score, oxygen saturation and Mean Arterial Pressure will be measured before and after each intervention (twice daily).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There is no standard sensory stimulation program for comatose patients with head trauma in the hospitals where the research will be conducted. Therefore, the control group will receive routine practice. |
| Auditory stimulus (Intervention A) | Experimental | Other: Auditory stimulusAuditory stimulus for patients in this group |
| Tactile stimulus (Intervention B) | Experimental | Other: Tactile stimulusTactile stimulus for patients in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
- 18 years and older
- Relatives of those who agreed to participate in the study
- GCS score between 3-8 (GCS: 3-8 indicates coma)
- Without hearing impairment
Key exclusion criteria (3 listed)
- Who are under the age of 18
- Those whose relatives do not agree to participate in the research
- GKS score above 8
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory stimulusAuditory stimulus will be applied to the patients in intervention group A. For the auditory stimulus, the sound recording of the relatives of the patients will be taken and the patients will be listened to with headphones. | Other | Auditory stimulus (Intervention A) |
| Tactile stimulusTactile stimulus will be applied to the patients in the intervention group B. The tactile stimulus will be performed by the researcher with a foot massage to be applied to the patient. | Other | Tactile stimulus (Intervention B) |
Primary outcome
Glasgow Coma Scale (GCS)
Time frame: 1 week
GCS is a diagnostic tool that provides objective evaluation of the patient's eye-opening, verbal and motor response to stimuli. In the scale, the eye opening score is between 1-4, the verbal response is between 1-5, and the motor response is between 1-6, and the total score is between 3-15. The GCS score of the patient who did not respond to painful stimuli, could not open his eyes spontaneously, and had complete loss of muscular tone was three; The GCS score of the patient who is oriented, spontaneously opens his eyes and fulfills the orders is 15. It should be understood that the patient with a GCS score of less than eight is in a coma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory stimulus and Tactile stimulus in people with Head Trauma and Traumatic Coma, run by Akdeniz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (GCS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.